[Federal Register Volume 64, Number 2 (Tuesday, January 5, 1999)]
[Notices]
[Page 518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95D-0349]


Draft Guidance for Industry on SUPAC-SS: Nonsterile Semisolid 
Dosage Forms, Manufacturing Equipment Addendum; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``SUPAC-SS: 
Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum.'' 
This draft guidance is intended to provide recommendations to 
pharmaceutical manufacturers using the Center for Drug Evaluation and 
Research's guidance for industry, ``SUPAC-SS Nonsterile Semisolid 
Dosage Forms, Scale-Up and Post Approval Changes: Chemistry 
Manufacturing and Controls; In Vitro Release Testing and In Vivo 
Bioequivalence Documentation'' (SUPAC-SS).

DATES: Written comments on the draft guidance document may be submitted 
by March 8, 1999. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of this draft guidance are available on the Internet 
at ``http://www.fda.gov/cder/guidance/index.htm.'' Written requests for 
single copies of the draft guidance for industry should be submitted to 
the Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug 
Evaluation and Research (HFD-357), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5633.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``SUPAC-SS: Nonsterile Semisolid 
Dosage Forms, Manufacturing Equipment Addendum.'' This document should 
be used in conjunction with the guidance for industry, ``SUPAC-SS 
Nonsterile Semisolid Dosage Forms, Scale-Up and Post Approval Changes: 
Chemistry Manufacturing and Controls; In Vitro Release Testing and In 
Vivo Bioequivalence Documentation'' (SUPAC-SS), which published in June 
1997 (62 FR 32352, June 13, 1997), in determining what documentation 
should be submitted to FDA regarding equipment changes made in 
accordance with the recommendations of the SUPAC-SS guidance document.
     This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). This draft 
guidance represents the agency's current thinking on equipment changes 
under SUPAC-SS. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute, regulations, or both.
     Interested persons may submit written comments on the draft 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The draft guidance and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: December 24, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-29 Filed 1-4-99; 8:45 am]
BILLING CODE 4160-01-F